25 batches of drugs of 18 pharma companies found substandard since Jan 2018 by BPPI

The Bureau of Pharma PSUs of India (BPPI), which implements the Centre’s flagship affordable medicine scheme PMBJP, has found 25 batches of drugs of 18 different pharmaceutical companies to be of substandard quality since January 2018, according to an official document.

While 17 out of the 18 companies are private, one is apublic sector unit (PSU) — Indian Drugs and Pharmaceuticals Limited (IDPL),according to the document.

   

Both the BPPI and the IDPL work under the Department of Pharmaceuticalsof the central government.

Once the affordable generic drugs are procured frompharmaceutical companies by the BPPI, they are supplied to various JanaushadhiKendras that are managed under the Pradhan Mantri Janaushadhi Pariyojana(PMBJP).

There are 4,677 Janaushadhi Kendras functional in thecountry, as on December 31, 2018.

Batches of two drugs of AMR Pharma India Private Limited –one an antidiabetic drug Voglibose and the other a hypertension drugTelmisartan – were found to be substandard by the bureau since January 2018,according to the official document, a copy of which PTI has accessed.

Just like AMR Pharma, batches of two drugs of the followingcompanies – Modern Laboratories, Legen Healthcare, Ravian Life Science, Maxchem Pharmaceuticals, Theon Pharmaceuticals, Mascot Health Series and TerracePharmaceuticals – were found to be substandard by the BPPI since January 2018,the document stated.

Batch number PZT0917 of Pantoprazole, which was manufacturedby IDPL, was found to be substandard by the bureau during 2018, it stated.

Pantoprazole is generally used to treat acid reflux andpeptic ulcers.

Painkiller Nimesulide and anti-fever medicine Paracetamol ofNavketan Pharma and Nestor Pharmaceuticals, respectively, were found to besubstandard by the BPPI, as per the document.

Hypertension drug Enalapril and antibiotic drugCiprofloxacin of Osmed Formulation and Hanuchem Laboratories, respectively,were found to be substandard since January 2018, it stated.

Other pharma companies that were found to be sellingsubstandard drug batches to the BPPI were Biogenetic Drugs, Wings Biotech,Zenith Drugs and Kwaility Pharmaceutical, according to the document.

As on February 8 this year, under the PMBJP scheme, the BPPIhas entered into a contract with 146 pharmaceutical manufacturing companies forprocuring generic medicines to be sold through dedicated retail outlets.

In response to queries sent by PTI, Sachin Singh, ChiefExecutive Officer (CEO), BPPI, said, “BPPI has taken stringent actionagainst the suppliers whose products were declared ‘Not of StandardQuality’.”

Singh gave a list of companies that have been debarred orblacklisted for selling “not of standard quality” products.

Seven companies — Overseas Health Care, HanuchemLaboratories, Legen Healthcare, AMR Pharma India Private Limited, JacksonLaboratories, Mascot Health Series and Terrace Pharmaceuticals — have beenblacklisted for a period of two years for supplying substandard drugs to theBPPI, according to this list.

Singh said whenever there is a market complaint, where aproduct is declared as substandard, certain steps are taken by the BPPI”with immediate effect”.

“Sale and distribution of batches identified as ‘Not ofStandard Quality’ is stopped to all level like CWH (Central Warehousing), CFA(Carrying and Forwarding Agent), distributor, Janaushadhi Kendras,” hesaid.

“The item is recalled from all levels like from CWH,CFA, distributor, Janaushadhi Kendras,” he said, adding “if sold,available stock (physical) is put at non-salable /quarantined areaseparately.”

After this, “technical documents like; out ofspecification investigation report, root cause analysis and Corrective andPreventive Action (CAPA) are collected from the supplier (company) onrequirement,” Singh said.

He said if satisfactory reply is not received from the drug supplier against the show cause notice issued by the BPPI, within the stipulated time, stringent action is initiated as per relevant clauses of the tender, such as forfeiture of security deposit, recovery of cost of entire batch, blacklisting or debarment of firm, among others. “Details of firms, blacklisted/debarred by BPPI are also disclosed for the public by hoisting it on our website,” he said. PTI

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